Three Novasep Custom Manufacturing Sites Renew FDA Approval in 2016

25.01.2017

Novasep announces that three of its custom manufacturing sites individually passed the general inspection process of the US Food and Drug Administration (FDA) free of any 483 form.

All three FDA general inspections have taken place at Novasep’s manufacturing sites in France (Mourenx and Le Mans), and in Germany (Leverkusen) over the course of 2016.

Novasep’s manufacturing site in Le Mans, France, produces highly potent cytotoxic active pharmaceutical ingredients (HPAPI) and registered advanced intermediates for commercial or clinical development use. The site also provides customers with regulatory and containment evaluation support. It produces paclitaxel, for which Novasep holds a valid Drug Master File and a European CEP (Certificate of Suitability). The site is also renowned for Antibody Drug Conjugate (ADC) payload production services that will soon be extended to ADC conjugation.

The manufacturing site in Mourenx, France, produces APIs and advanced intermediates.

Novasep’s site in Leverkusen, Germany, amongst its set of technical expertise, can handle hazardous chemicals at industrial scale. This know-how is particularly suitable for designing shorter, cost-effective synthetic routes for producing APIs and advanced intermediates. The site also produces and sells pre-formulated nitroglycerin products for the pharmaceutical market.

In each case, the FDA inspection confirmed that commercial APIs produced at each site are suitable for drugs marketed in the US.

“This success has been made possible by the day-to-day good practices adopted by every colleague involved in operations. The robust system implemented by Novasep’s quality assurance team ensures these high standards,” said Jean-Claude Romain, VP quality at Novasep. “These three successful inspections reward this long-term teamwork and commitment.”

Global professional juries have recognized Novasep several times for the reliability and the robustness of its quality system.

More articles on this topic

Final Report ACHEMA 2022

08.09.2022 -

At ACHEMA 2022, the world’s leading trade show for the process industry, over 2,200 exhibitors from more than 50 countries showcased the latest equipment and innovative processes for the chemical, pharmaceutical and food industries at the Frankfurt fairgrounds from 22 to 26 August.

Read more

Reliable in Use for 25 Years – ABEL EM-Pump

15.06.2022 -

Reliable, robust and energy-saving – these are three key features of ABEL Electric Diaphragm Pumps (EM). In 2022, the ABEL EM will celebrate its 25th anniversary. With its start at Achema 1997, ABEL introduced a completely new and patented drive principle that revolutionized the pump market.

Read more